National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Tuberculosis Laboratory Aggregate Report, Fifth Edition – 2015–2017
Monica Youngblood, MPH, M(ASCP)CM
Microbiologist/Laboratory Consultant
11th National Conference on Laboratory Aspects of Tuberculosis
April 24, 2019
Division of Tuberculosis Elimination
Background on TB Laboratory Aggregate Report
Is published every two years
Contains analysis of self-reported TB testing data from CDC TB Elimination Cooperative Agreement (CoAg) public health laboratory (PHL) awardees
Aggregates PHL TB workload and performance indicator data, including: – Mycobacterium tuberculosis complex (MTBC) culture positivity
– Nucleic acid amplification testing (NAAT)
– Turn around time (TAT) trends
– Testing methods
Purpose
Provides data back to CoAg awardees in aggregate, and evaluates trends
Encourages laboratories to:– Review national averages and trends
– Evaluate laboratory specific data against peer data
– Monitor/assess internal workload and TAT indicators
– Track progress and set goals
Assessment
TB laboratory supervisors or their designees were invited to participate in an evaluation of the Fourth Edition of the report, in April of 2017– Survey contained 13 multiple choice and 6 free-text questions
Response rate was 72% (42/58)
PHLs used the report to:– Compare internal laboratory culture positivity and TAT data to data
reported by other PHLs
– Document accomplishments within the laboratory
– Increase local awareness of PHL TB laboratory services, and of the impact of these lab services within the state
Assessment (2) Data assisted PHLs to:
– Update specimen criteria protocols
– Monitor turnaround time data more effectively
– Suggest or implement new methodologies including IGRA, molecular assays, and Maldi-TOF
Suggested elements/domains to add to future reports included:
– IGRA testing (location of testing in the TB lab vs another lab; choice of specific test used)
– Staffing levels for TB testing in PHL
– 5-year trends of NAAT and identification (ID) methods
– Drug susceptibility testing (DST)
– Barriers/challenges to meeting national TB benchmarks for PHLs
Information was used by CDC to plan for the Fifth Edition
Change in National Workload, 2015–2017Three Year Change
No. (% change)
Clinical specimensa received -5,644 (-2.7)Patients for whom a specimen was submitted -5,469 (-5.9)
Patients culture positive for MTBC +149 (3.9)
Patients culture positive for MTBC that were NAAT positive
-168 (-7.9)
Patients tested by NAAT or other rapid testb +150 (0.7)Patients NAAT positive for MTBCb -704 (-21.7)Patients for whom a reference isolate was submittedc +339 (2.2)
Patients with a reference isolate identified as MTBC +71 (2.1)
Patients for whom DST was performed -334 (-5.6)
IGRA +17,310 (18.9)aProcessed and cultured, not including isolates referred from other laboratories, bIncludes sediments received only for NAAT, cReceived to either rule out or confirm the identification of MTB
Recovery of MTBC (Culture Positivity)
National TB Laboratory Cooperative Agreement Aggregate Data, 2017
Nationally, in 2017 approximately 4.6% culture positivity was seen for MTBC among PHL. The range of culture positivity was broad, from a low of 0% to a high of approximately 32.2%.
0.21.2
2.5
4.6
7.17.8
10.7
19.3
28.0
32.2
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
Perc
ent
pat
ien
t sp
ecim
ens
rece
ived
th
at w
ere
cult
ure
po
siti
ve f
or
MTB
C (
all s
pec
imen
s)
Trends in NAAT Utilization and Performance, 2015–2017
3293
18841476(45%)
3297
1778 1498(45%)
3578
1762 1558(44%)
0
500
1000
1500
2000
2500
3000
3500
4000
Number of patients with MTBCpositive culture
(Workload Indicator 2a)
Number of patients with MTBCpositive culture with a positive
NAAT(Workload Indicator 2b)
Number of patients with MTBCpositive culture with a postive
NAAT reported within 48 hours(Healthy People 2020)
Nu
mb
er
of
Pat
ien
ts
2015 (n=52) 2016 (n=48) 2017 (n=50)
Turnaround Times, 2017
*67%
*92%
*74%
*69%
*National Target
57%
81%
95%
48%
77%
77%
93%
48%
52%
72%
91%
53%
57%
72%
85%
46%
0% 20% 40% 60% 80% 100%
DST: % rifampin w/in 17 days of ID
ID: % w/in 21 days
Smear: % w/in 1 day
Specimen Receipt: % w/in 1 day
Percent of specimens meeting benchmark
<2,000 (n=25; n=23 DST & ID) 2,001-5,000 (n=21) 5,001-8,000 (n=7) >8,001 (n=5)
Ranges of clinical specimens received
NAAT Methods, 2018
Cepheid Xpert MTB/RIF, 36
Real-time PCR, 15
Hologic Amplified MTD, 2
Referred, 4Pyrosequencing, 1
Primary ID Methods, 2018
Hologic Accuprobe, 30
HPLC, 7
Real-time PCR, 6
Maldi-TOF, 5
Cepheid Xpert MTB/RIF, 2
Fujirebio INNO-LiPA, 2
Referred, 2
Sequencing, 2PRA, 1 PCR Melting Curve Analysis, 1
First-line DST Methods, 2018
Bactec MGIT, 38
Referred—DST Reference Center, 14
Referred—Other Laboratory, 4
Indirect AP, 1 Thermo Scientific
Sensititre, 1
Molecular Testing for Detection of Drug Resistance, 2018
*Performed on culture growth
Targeted Sequencing, 5
Cepheid Xpert MTB/RIF*, 2
Whole Genome Sequencing*, 1
Bruker MTBDRplus Line Probe Assay, 1
IGRA Methods, 2018
None, 28
Qiagen QuantiFERON in other section of
PHL, 20
Qiagen QuantiFERON in
Mycobacteriology Laboratory, 8
Oxford Immunotec T-
Spot.TB, 2
Final Thoughts
Public Health TB Laboratory role differs
Decreasing specimen volume and increasing culture positivity
Shifting test methodologies
Self-reported data were analyzed for this report
Important to monitor your laboratory specific data, and to compare findings with national data
All reports/editions are available on the internet: https://www.cdc.gov/tb/publications/reportsarticles/labreports.htm
Fifth Edition Aggregate Report will be released later this year
Thank you for evaluation responses and feedback
For more information, contact CDC1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348 www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.